IntroductionMost Americans rely on some private insurance system to pay for their health care. Insurance, however, is not a government-provided service or a utility. It is private enterprise, and for that reason insurers have an incentive to maximize their profits by providing as little coverage as contractually and legally possible, while continuing to collect regular premiums from their insureds. Although persuading an insurer to pay for human growth hormone treatment for wasting syndrome may feel like a fight over a basic right to health care, in the eyes of the law it is only a dispute over the interpretation of a contract. If you want cutting edge HIV treatment, it is likely that at some point your insurance company will deny a claim for benefits, and you will have a dispute on your hands. Although not intended to give you specific legal advice, this article will introduce you to some legal principles that may be of use in getting and keeping your care covered. As in all matters, it is important to know your rights and be ready to exercise them. The Requirement of Medical Necessity, and Exclusions for Experimental TreatmentsMost health insurance contracts require the insurer to pay for all health care claims that are "medically necessary," unless the treatment is specifically excluded by the terms of the policy, such as exclusions for "experimental" or "investigational" treatments. If your insurer denied your claim, it is important for you to ascertain the exact grounds on which it was rejected. Does your insurer claim that the procedure or treatment is not necessary, or that it is considered experimental, or that it is not approved for the particular use to which it is being put? For each of those grounds, you may need to respond with different arguments and evidence. A. Demonstrating the Treatment is Medically NecessaryMost insurance contracts oblige insurers to pay only for procedures that are "medically necessary." Coverage for innovative procedures is often denied because these treatments may not have sufficient track records to render them obviously "necessary." The law can work to your advantage in this kind of coverage dispute. First of all, courts tend to interpret insurance contracts liberally in order to provide the broadest possible coverage. In the course of your dispute, be sure to remind your insurer of this fact. The focus of a dispute over medical necessity is less on the treatment than on you. Certainly you can and should submit evidence that the treatment has been useful for others. But especially compelling is evidence that you have undergone all the other available treatments for the particular condition, and they have not been or have ceased being effective for you. If you have been able to use the disputed treatment, either paying for it out of pocket or through a trial protocol, and have a personal history of benefit from this procedure, it will be hard for your insurer to defend the position that the treatment is unnecessary. B. Demonstrating the Treatment is not "Experimental" as Defined in the PolicyIt is more likely that your insurer will deny a claim based on the assertion that the procedure is "experimental" or "investigational" in nature. If so, the first thing you must do is look at the insurance contract itself, to determine how the term "experimental" is defined. The law says that ambiguous terms in an insurance contract must be interpreted by a court in favor of the insured--not in favor of the insurer. The reason for this is that the insurer wrote the contract and had the opportunity to make everything clear. It therefore should not have the right to benefit from its own failure to draft a clear contract. Many courts across the country have ruled that the term "experimental" is by nature ambiguous if it is not defined in the policy. Without a specific definition, it can be interpreted in numerous ways: procedures performed only for research purposes; procedures performed to benefit a patient, the results of which will be shared with researchers; etc. If "experimental" is not defined in your policy, a court may agree with you that the treatment you need is not experimental, and should be covered. For this reason, many policies do attempt to define "experimental." Some policies do so by referring to the findings of specific medical authorities, for instance whether or not the treatment has been approved by the FDA. If the treatment you need is considered experimental by the medical body named in the policy, you will not be able to effectively argue that the policy is ambiguous. (You could perhaps go to court and argue that in the context of HIV care, which develops far more rapidly than "official" medical bodies can evaluate, a person with HIV would NEVER be able to get coverage for the newest treatments if the exclusion is constructed this way. Since this catch-22 might cause you irreparable harm, the court should not enforce the policy exclusion, even though the exclusion itself is clear. Be aware that this is a hard type of challenge to win, and you should consult with a lawyer to determine if it is worth pursuing in your case.) If, on the other hand, your policy's definition of "experimental" does not specifically name a medical authority whose determination will be relied on, but instead refers more vaguely to "appropriate medical bodies," you can once again argue that this definition of "experimental" is ambiguous and that the treatment you need is not experimental as defined in the policy. By pointing out that your policy's definition of "experimental" is ambiguous, you create an opportunity to demonstrate why the treatment you need is NOT experimental. Here are some points your evidence should address:
If other insurers interpret their own policies to permit coverage, then the procedure is not unambiguously "experimental." In addressing effectiveness, try to touch upon community experience with the procedure, including the procedure's effect on health outcomes (long term survival, likelihood of recurrence of the condition, risks and side effects) when compared to other treatments as well as to no treatment at all. Certainly your doctor's assessment will be central to your position. But since the insurer has presumably already heard and discounted your physician's recommendation, seek out testimony from other HIV specialists in the community to support your doctor's opinion. Find out if they consider this procedure to reflect the community standard of care. How long have they been using this procedure? Some courts have ruled that sufficient history of use of a treatment in the community makes it non- experimental, even without literature on it and even if there are side effects to the procedure. C. Demonstrating that a Particular Use of a Treatment is Not Experimental.Some insurers will attempt to deny or limit coverage for "off-label" uses of an otherwise FDA-approved drug or treatment. This means that although a drug may be FDA- approved for some uses, it is not specifically approved for treatment of your condition. In some states there are statutes specifically addressing this question. In California, for example, if an insurance policy pays for FDA-approved drugs, it must also reimburse for "off-label" uses of these drugs for individuals with life-threatening health conditions, provided that you can show that the new use is effective. Under the law, you can do this by pointing to certain medical authorities, or two articles from major peer-reviewed medical journals. If your state does not have explicit law on the topic of "off-label" coverage, you will have to address the problem as you would if you were fighting for coverage for an experimental treatment, as discussed above. D. Making the Economic ArgumentAlthough not relevant for determining whether a procedure is experimental, you should make a cost-effectiveness argument if there is any way to do so. Insurers, in their zeal to deny as much coverage as possible, sometimes lose track of the fact that paying for some new treatments may save them money. If the procedure is less expensive than the non-experimental alternatives, state that. If it is less expensive in the long run than not treating the condition at all, say so loudly. Even an expensive preventive measure may be more cost- effective than treating the condition that could have been prevented. Or paying for a diagnostic such as a viral load test may permit a physician and patient to decide against expensive anti-viral therapy. Handling Your DisputeA. Available Legal RemediesIf your insurance claim is denied, you should be able to appeal the decision within the insurance company (and you may be required to do so before pursuing the case further). Although it is still the insurer making the decision, many individuals succeed in changing an insurer's mind at the appeal level, using the arguments and evidence suggested above. If your insurer does not budge, you can consider suing it for failure to pay the claim. If you succeed, you will be reimbursed for any money you advanced in order to undergo the treatment. In a few instances--namely if your policy is an individually purchased policy, rather than a benefit of your employment--you can sue your insurer for additional damages. For instance you might have a "bad faith" claim if the insurer's behavior was particularly outrageous. Or you may have a claim for other consequential damages, for instance for a worsening of your condition due to their failure to pay for a procedure. If your insurer is unwilling to settle the case out of court, be aware that a lawsuit could take years to complete and may cause you more stress than you are willing to put up with. Talk to an attorney and consider these questions seriously when determining how far you are willing to go. If you need the procedure in question immediately, and do not have the money to pay for it in hopes you will win your court case later, you can consider having an attorney file in court for an injunction. By doing this, you would be asking a court to interpret the insurance policy and rule in advance that the insurer must pay. If you have your medical evidence gathered, a hearing could be held within days of filing. This procedure can be expensive, and you may be required to post a bond while your full court case is pending. B. Obstacles to Exercising Your Rights
Some HMOs have provisions in their policies requiring members to submit to binding arbitration regarding all disputes with the carrier. If you are a member of such a system you will be required to have your dispute adjudicated through arbitration --a less formal proceeding than a court trial. The arbitrators will resolve the dispute based on the same legal principles that would guide a court of law. The arbitrators' decision will be final, unless there was some impropriety in rendering the decision, in which case you could then appeal to a court. Simply rendering a decision that is unfavorable to you does not give you grounds to appeal. If you receive your health care coverage through an employer, your rights are substantially less than if you individually purchased an insurance policy. This is due to a federal law known as ERISA (Employee Retirement Income Security Act of 1974) which was passed to protect employees against the risk of their employers squandering their pension money. The law addresses not merely retirement plans, but all benefits plans, including health benefits. Unfortunately, ERISA says virtually nothing about the contents of health benefits plans, while at the same time it supersedes all state laws touching on those plans. The net effect is this. All state law-based claims against your insurer, such as bad faith, fraud, negligence and infliction of emotional distress disappear. You may sue only for payment of the claim itself, and not for other damages arising out of the insurer's failure to pay. Insurers therefore have little incentive to pay your claim, because the worst that can happen to them if you sue is that they will have to pay the claim and possibly your attorney's fees. They will not be on the hook for any greater damages. ERISA will also affect how a court rules on the coverage question. If the health benefits plan grants the plan administrator (the insurance company, or sometimes the employer itself in cases of large "self-insured" plans) discretion to interpret the terms of the plan, the court can only overturn the insurer's coverage decision if that decision was "arbitrary and capricious" or an "abuse of discretion." In practice, as long as the coverage decision reflects a reasonable interpretation of the policy--even if the policy language is ambiguous--the insurer will prevail. If, however, the policy does not specifically grant that discretion to the plan administrator, the court is free to examine the coverage decision afresh. This is a very basic outline of ERISA and insurance coverage. If you have an employer-provided health plan and are in a coverage dispute, you will need to consult a lawyer. Going Public: Using Outside PressureA. Organizing a Campaign Against Your Insurer or HMOIf your insurance carrier refuses to cover a particular promising HIV treatment or procedure, such as human growth hormone for wasting syndrome, or viral load tests as an immune system marker, you may be able to achieve a change in the policy by banding together with other HIV positive individuals using the same carrier. Although you may be skeptical, insurance companies, and especially regional HMOs, are concerned about their public image. They must compete to attract members, and denying coverage of treatments for people with a life-threatening illness does not inspire confidence among their potential insureds. You may wish to seek out activists, through organizations such as ACT UP or the People With AIDS Coalition. Consider having demonstrations or sending out press releases regarding the particular practice. The threat of public exposure is especially effective immediately before "open enrollment," when employees are choosing their health care delivery system. Open enrollment periods most frequently occur around the new year. You may wish to consider letters to large progressive employers asking them not to renew their contracts with this insurer until it changes its policy regarding coverage of this treatment. Remember that a public campaign is a means to achieve your purpose (e.g. coverage of certain treatments, changes in policy, etc.), and not an end in itself. For that reason, you should be sure to inform the insurer of all the steps you are taking and when you are taking them, so that it always has the option to give in to your demands. B. Using the GovernmentFind out for certain which governmental body in your state regulates your insurer. In California, for instance, the Department of Insurance regulates only a small number of health insurers, while the Department of Corporations regulates the vast bulk of them, including all HMOs. The federal Department of Labor regulates ERISA claims. Find out what that body can do for you. Is there a consumer complaint line? What powers does it have? Be sure to send that body copies of all your correspondence with the insurer. Your elected officials may be of use also. No insurer likes getting calls from members of Congress. Also, local officials may have the power to cease contracting with the insurer for health care for city or county employees. Your insurer may very much want to keep your county or municipality as a happy customer. ConclusionGetting proper care for HIV often requires you to be your own advocate. With some effort, you can also be an effective advocate in dealing with your insurance company. Do not accept denials of coverage as "done deals." Find an AIDS legal service organization in your area by calling an AIDS service provider or a local bar association, and consult with a lawyer to learn your rights. The decision to exercise them is yours. For more information: The AIDS Legal Referral Panel, 415/291- 5454, focuses on the San Francisco Bay Area, but can refer people to similar agencies throughout the country.
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CD8 Cells: by John S. James
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Nine years ago researchers at the University of California San Francisco Medical Center reported that CD8 cells could produce a soluble substance or substances which could slow or stop the growth of HIV.(1) When the CD8 cells were taken out of the infected cell culture, HIV grew again; when they were added back, HIV growth stopped. Direct contact was not needed, as the CD8 cells could be in a separate compartment, separated from the infected cells by a filter, and they still stopped HIV growth. Laboratory studies of samples from patients showed that in those whose disease progressed, the CD8 cells lost much of their ability to inhibit HIV in this way. Unfortunately, efforts to identify the substance or substances were unsuccessful; however, other research indicated that the mechanism of action seemed to be inhibition of the LTR (long terminal repeat) of HIV.
In December 1995, four such inhibitory substances were reported. Three were found by researchers at the U.S. National Cancer Institute Laboratory of Tumor Cell Biology, then run by Robert Gallo, M.D.; these need to work together, as each substance alone had little or no effect.(2) Also in December, a separate research team in Germany reported a fourth inhibitory substance, in a letter to NATURE. All four of these turned out to be substances which were previously known. (Note: Several members of the research team at the NCI are now joining Dr. Gallo at the Institute for Human Virology, a new research center at the University of Maryland.) Gallo's laboratory used fairly straightforward procedures to discover three of the substances, which are proteins and members of a class called chemokines, substances involved with inflammation and which cause cells to move. First, the researchers set up a laboratory test to measure the amount of suppressive activity in a given sample. Then they selected cells which produced large amounts of this factor. To find out what it was, cell-free material from the cultures was chemically fractionated (separated) and purified in various ways, and then tested to see which fractions kept the suppressive activity and which lost it. Finally, two fairly pure substances could be analyzed by standard methods to determine what amino-acid sequence a protein contains. The sequences turned out to be identical to those of substances already known. Additional tests confirmed that these two were indeed correctly identified. (The third substance was tested for because it was very similar to one of the first two. It also was found to be present in the samples.) As additional confirmation, antibodies to the three proteins were prepared. In cultures from three of four patients tested, they blocked all of the suppressive activity; in the fourth patient, they blocked 80% of it. Antibodies are quite specific in what proteins they recognize; the antibodies in this test would have had little activity except to block the action of the three proteins they were targeted against, showing that those proteins were responsible for the suppressive activity. No one knows if these proteins themselves would be effective treatments. Some substances (such as IL-2) are produced by the body and tend to be used locally, by nearby cells; injecting a large amount systemically may not work the same way. But the identification of these three substances is certainly important for new-drug development, whether or not a final drug turns out to be a cocktail of these three, or something else. Also, measurement of these substances in the blood might serve as a marker of AIDS progression, or of the therapeutic effects of certain drugs, or of the protective effect of preventive vaccines. The researchers noted that clinical studies of these newly identified proteins "will be critical to define their role in the natural history of HIV infection." References1. Walker CM, Moody DJ, Stites DP, Levy JA. CD8+ lymphocytes can control HIV infection in vitro by suppressing virus replication. SCIENCE December 19, 1986; volume 234, pages 1563-1566. 2. Cocchi F, DeVico AL, Garzino-Demo A, Arya SK, Gallo RC, and Lusso P. Identification of RANTES, MIP-1-a, and MIP-1-b as the major HIV-suppressive factors produced by CD8+ T cells. SCIENCE December 15, 1995; volume 270, pages 1811- 1815.
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AZT plus 3TC |
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Results of a double-blind study comparing AZT plus 3TC (also called lamivudine, or Epivir(TM) vs. either drug alone, in 366 patients with CD4 between 200 and 500 who had previously taken little or no AZT, were formally published December 21 in THE NEW ENGLAND JOURNAL OF MEDICINE.(1) The combination clearly showed better and more lasting results than either drug alone in CD4 improvement and in decrease of viral load, throughout the one year of the study.
These results are not new, as they were presented at conferences a year ago. But formal publication is still important, because the results are more thoroughly checked and more completely described than at the early oral presentations. Another paper in the same issue of the journal reported findings from a 32-patient study that 3TC was also effective against hepatitis B. References1. Eron JJ, Benoit SL, Jemsek J, and others. Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. THE NEW ENGLAND JOURNAL OF MEDICINE. December 21, 1995; volume 333, number 25, pages 1662-1705.
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Opportunistic Infection Prevention: |
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The National Association of People with AIDS (NAPWA) and the National Association of Nurses in AIDS Care will sponsor a video symposium on prevention of opportunistic infections, including discussion of pneumocystis, CMV, and other related issues, on January 11 in the following cities: Chicago, Houston, Los Angeles, Miami, New York, San Francisco, and Washington D.C. The time is 1:00 - 2:30 Pacific time, 3:00- 4:30 Central time, 4:00 - 5:30 Eastern time.
The program is free, but registration is requested. To register, and find the location in your city, call the NAPWA CMV Prevention Hotline, 800/838-9990.
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San Francisco: |
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On December 19 the San Francisco Health Commission voted unanimously to order the San Francisco Department of Public Health to "inform persons who are immunocompromised about the risks of drinking untreated San Francisco tap water," and to take other measures to protect public health, due to cryptosporidium parasite in the water. Cryptosporidium causes cryptosporidiosis, characterized by severe diarrhea; persons with a healthy immune system usually recover in one to two weeks, but for persons with severe immune deficiencies, the infection can be life threatening. According to a fact sheet from the California Department of Health Services, persons with a serious immune system problem should use distilled or properly boiled water; but the low levels of cryptosporidium found in California public drinking water systems should not be a health concern to the general public.
The San Francisco alert resulted from work by AIDS activists, who have intensively studied this issue--not from the city AIDS office. "The Health Commission overruled the bureaucrats running the AIDS office and admitted that there is a problem," commented ACT UP Golden Gate member Bill Thorne. For more information, contact ACT UP Golden Gate, 415/252- 9200, or fax 415/252-9277. ACT UP Golden Gate has prepared a report, CRYPTOSPORIDIUM: CURRENT ISSUES IN BIOLOGY, LAW, MEDICINE, AND WATER QUALITY, by Rob Sabados, which is available for a $5 suggested donation.
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Computer Censorship Update |
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AIDS Treatment News has published three articles about the computer censorship bill which is now in Congress, attached to the major telecommunications deregulation bill (AIDS Treatment News #237, #236, and #227). This bill would make it a felony to transmit most safer-sex information to the public by computer. Unintended consequences would damage our treatment information work by making it difficult to host an uncensored computerized public forum on any topic, and difficult to link a Web site to foreign sites. Also, universities and other institutions will be pressured to block public access to huge databases and archival collections now available, due to the cost of hand-checking all of it to assure compliance; even if Congress or the courts later change the law, the existing tradition of openness may never fully recover.
The bill is still in Congress. After our last issue had gone to press, it looked like a bipartisan compromise on other contents of the telecommunications bill could lead to passage by Christmas; President Clinton promised to sign that bill, which included the censorship provision. But then the compromise fell apart. It is likely that major areas will now need to be renegotiated; Congress may act in February. Many outcomes are possible, from passage of the current bill, to removal or compromise of the censorship provisions, to partisan dispute preventing the passage of any telecommunications bill until after the presidential election. A measure of the confusion is that there has not yet been a complete copy of the actual bill embodying the House/Senate compromises; Congress had been expected to vote final approval of this major legislation long before a complete draft even existed. Whatever Congress does, we will have to face this issue for a long time. If the censorship provisions become law, there will be years of litigation; if not, the issue will come back to Congress again and again. AIDS organizations have not been engaged, and were not represented when the censorship provisions were adopted. We must start now to work with civil libertarians and others so that our voices will be heard about legislation which could greatly damage the future effectiveness of AIDS services and activism.
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Activist Groups and PWA Coalitions, Updated January 1996 |
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Since 1990 AIDS Treatment News has published a list of ACT UP chapters, PWA coalitions, and buyers' clubs. This year the buyers clubs are listed separately. We called these numbers and listed only those we could verify; some are home telephones, not offices. Within states, the listings are alphabetical by city.
For information about ACT UP affiliates, call the ACT UP Network, 215/731-1844. For information about other PWA organizations, call the National Association of People Living With AIDS (NAPWA), 202/898-0414. If you know of organizations which you think should be included in next year's directory, please call AID TREATMENT NEWS at 800/TREAT-1-2. Remember that there are well over ten thousand AIDS organizations in the U.S. alone; only a few can be included in this specialized list. To find out about services and organizations in your area, call the National AIDS Hotline, 800/342-AIDS, 24 hours a day; for the same information in Spanish, call 800/344-SIDA, 8 a.m. to 2 p.m. Eastern time, 7 days a week.
Buyers' Clubs and Other SuppliersThe following list is in order alphabetically by name of the state. All of them provide mail-order service. We cannot endorse or recommend specific groups, but we have worked most closely with Healing Alternatives Foundation, and with PWA Health Group. [Note: Cannabis buyers clubs are not included here but will be listed separately in a later issue.] Being Alive Buyers' Club, 111 E. Camelback Rd., Phoenix, AZ 85012, 602/265-2437, 602/265-7201 fax.PACT Buyers' Club, 801 W. Congress St., Tuscon, AZ 85745, 520/770-1710, 520/622-5822 fax. DNCB Group, 2261 Market St., #436, San Francisco, CA 94114, 415/954-8896 (DNCB only). Healing Alternatives Foundation, 1748 Market St. #205, San Francisco, CA 94102-5806, 415/626-4053, 415/626-0451 fax. CFIDS Buyers' Club, 1187 Coast Village Rd. #1-280, Santa Barbara, CA 93108, 800/366-6056, 805/965-0042 fax. LifeLink, 445 Lierly Lane, Arroyo Grande, CA 93420, 805/473-1389, 805/473-2803 fax. Embrace Life, 2070-C Wharf Road, Capitola, CA 95010, 800/448-1170, 408/476-7717 fax. Denver Buyers' Club, P.O. Box 300339, Denver, CO 80203, 303/329-9379, 303/329-9381 fax. Carl Vogel Foundation, 1010 Vermont Ave. NW, #510, Washington, DC 20005-3405, 202/638-0750, 202/638-0749 fax. AIDS Manasota, 2080 Ringling Blvd., #302, Sarasota, FL 34237-7030, 813/954-6011, 813/951-1721 fax. Wholesale Health, 909 NE 18 St., Ft. Lauderdale, FL 33305, 305/764-1587. Health Link, 3213 North Ocean Blvd., #6, Ft. Lauderdale, Fl 33308, 305/565-8284, 305/565-8289 fax. Life Extension Foundation, P.O. Box 229120, Hollywood, FL 33022-9120, 800/841-5433, 305/989-8269 fax. AIDS Treatment Initiatives, 125 5th St. NE, Atlanta, GA 30308, 404/874-4845, 404/874-9320 fax. Boston Buyers' Club [SPV-30], 163 W. Brookline Street, Boston, MA 02118-1279, 617/266-2223, 617/424-0122 fax. PWA Health Group, 150 West 26th Street, #201, New York, NY 10001, 212/255-0520, 212/255-2080 fax. DAAIR, 31 E. 30th Street, #2A, New York, NY 10016, 212/725-6994, 212/689-6471 fax. Prince St. Market/Houston Buyers' Club, P.O. Box 131594, Houston, TX 77219, 713/880-2338, 713/880-2338 fax. People Curing AIDS, 1314 Pine St., Seattle, WA 98122, 206/233-8048 message line. Canada Canadian Nutrition Club, P.O. Box Q4, Jasper, ON K0G 1G0, 613/284-0076, 613/284-2789 fax. Supplements Plus, 2304 Bloor Street West, Toronto, ON M6S 1P2, 416/977-3088, 416/977-3099 fax. |